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  • ISE Sample Pretreatment - DM-Manuf

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    Amraa Baasankhuu
    24 views3 pages
    The document provides manufacturing information for ISE Sample Pretreatment reagents. It states that Roche Diagnostics GmbH manufactures the reagents in Mannheim, Germany under an ISO 13485 certified quality management system. An overview of the general manufacturing process is given, including preparing a matrix, adding substances, in-process control, primary packing by filling, secondary packing, and quality control testing and release.

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    ISE Sample pretreatment_DM-Manuf

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    The document provides manufacturing information for ISE Sample Pretreatment reagents. It states that Roche Diagnostics GmbH manufactures the reagents in Mannheim, Germany under an ISO 13485 certified quality management system. An overview of the general manufacturing process is given, including preparing a matrix, adding substances, in-process control, primary packing by filling, secondary packing, and quality control testing and release.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Flag for inappropriate content
    24 views3 pages

    ISE Sample Pretreatment - DM-Manuf

    Uploaded by

    Amraa Baasankhuu
    The document provides manufacturing information for ISE Sample Pretreatment reagents. It states that Roche Diagnostics GmbH manufactures the reagents in Mannheim, Germany under an ISO 13485 certified quality management system. An overview of the general manufacturing process is given, including preparing a matrix, adding substances, in-process control, primary packing by filling, secondary packing, and quality control testing and release.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Flag for inappropriate content
    of 3

    �-

    Design and Manufacturing


    Manufacturing Information

    ISE Sample Pretreatment: e 411/601/602 (REF 05889073


    190

    13.Mar.2019 V. Bauer
    Global Regulatory Affairs

    CONFIDENTIAL AND PROPRIETARY


    DM-Manuf
    Page 1 of 3
    1. Manufacturer Information

    Legal Manufacturer:

    The ISD Sample Pretreatment reagents are manufactured by Roche Diagnostics GmbH (RDG).

    The address is as follows:

    Roche Diagnostics GmbH


    Sandhofer Strasse 116
    D-68305 Mannheim
    Germany

    2. Quality Management System

    The above mentioned Roche manufacturing facilities are certified under a Quality
    Management System according to ISO 13485.

    3. Manufacturing

    A general overview of the manufacturing process is provided in the attached


    manufacturing flowchart.

    CONFIDENTIAL AND PROPRIETARY


    DM-Manuf
    Page 2 of 3
    Manufacturing Flowchart
    For Auxiliaries

    Components

    Prepare matrix

    Add substances

    In process Control

    Primary packing:
    Filling

    Secondary packing

    QC test and release

    CONFIDENTIAL AND PROPRIETARY


    DM-Manuf
    Page 3 of 3

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